Comparison of Dendritic Cells Versus Montanide as Adjuvants in a Melanoma Vaccine

NCT ID: NCT00124124

Last Updated: 2015-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-31
• Study Completion Date: 2009-04-30

Brief Summary

In this study, a melanoma vaccine (5 melanoma peptides) is given with either Montanide or dendritic cells as adjuvants. This randomized trial will establish the safety of both vaccines and compare the 2 vaccine adjuvants in their efficacy to induce immune responses.

Detailed Description

In this study, we will examine whether DCs pulsed with candidate melanoma-specific peptides and KLH can boost CTL responses to melanoma antigens in melanoma patients who are clinically free of disease but at high risk for recurrence. This vaccine will be compared to direct injection of the same peptides with KLH and Montanide as adjuvant.

Conditions

Melanoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

KLH and peptide pulsed DCs

Group Type: EXPERIMENTAL

KLH; Peptides; Dendritic Cells

Intervention Type: DRUG

Upon entry into the study, patients randomized to the dendritic cell arm will undergo a complete baseline evaluation and leukapheresis 0.5 to 3 x 106 DCs per peptide antigen (total not to exceed 18 x 106 cells) will be administered intradermally as per injection SOP. They will receive up to 3 booster DC injections (total not to exceed 18 x 10 6 cells per injection) at monthly intervals for a total of 4 injections. The booster injections will not contain KLH, as our volunteer studies have shown that priming occurs following a single injection of DCs

2

KLH, peptides plus Montanide

Group Type: EXPERIMENTAL

KLH, peptides plus Montanide

Intervention Type: DRUG

Patients randomized to the Montanide arm will also undergo complete baseline evaluation but not leukapheresis. The peptides will be mixed with the adjuvant, Montanide, and administered subcutaneously at a dose of 100 microgram of each peptide +100 microgram KLH mixed with an equal volume of Montanide. They will receive up to 3 booster injections at monthly intervals for a total of 4 injections. The booster injections will not contain KLH.

Interventions

KLH; Peptides; Dendritic Cells

Upon entry into the study, patients randomized to the dendritic cell arm will undergo a complete baseline evaluation and leukapheresis 0.5 to 3 x 106 DCs per peptide antigen (total not to exceed 18 x 106 cells) will be administered intradermally as per injection SOP. They will receive up to 3 booster DC injections (total not to exceed 18 x 10 6 cells per injection) at monthly intervals for a total of 4 injections. The booster injections will not contain KLH, as our volunteer studies have shown that priming occurs following a single injection of DCs

Intervention Type: DRUG

KLH, peptides plus Montanide

Patients randomized to the Montanide arm will also undergo complete baseline evaluation but not leukapheresis. The peptides will be mixed with the adjuvant, Montanide, and administered subcutaneously at a dose of 100 microgram of each peptide +100 microgram KLH mixed with an equal volume of Montanide. They will receive up to 3 booster injections at monthly intervals for a total of 4 injections. The booster injections will not contain KLH.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Resected stage IIB, IIC, or stage III melanoma.
• Fully recovered from surgery
• Human leukocyte antigen (HLA) A*0201 positive.
• Age >18 years.
• Karnofsky performance status: >80% and normal labs.

Exclusion Criteria

• Prior chemotherapy.
• Known chronic infection with HIV, hepatitis B or C.
• Patients with known autoimmune disease [e.g. systemic lupus erythematosus (SLE), rheumatoid arthritis (RA)]. Patients with vitiligo are not excluded.
• Pregnant women.
• Patients with known allergy to gentamicin, tobramycin, streptomycin and amikacin (risk of cross-reaction between aminoglycosides).
• Patients who have known retinal or choroidal eye disease.
• Patients previously treated with one of the peptides used in this trial, melanoma protein vaccine, melanoma whole cell vaccines, or with Montanide are not eligible.
• Allergy to shellfish.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cancer Research Institute, New York City

OTHER

Sponsor Role: collaborator

Dr. Nina Bhardwaj

INDIV

Sponsor Role: lead

Responsible Party

Dr. Nina Bhardwaj

Director, Tumor Vaccine Program

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sylvia Adams, MD

Role: STUDY_DIRECTOR

NYU Langone Health

Nina Bhardwaj, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYU Clinical Cancer Center

New York, New York, United States

Countries

United States

Other Identifiers

NYU 02-10

Identifier Type: -

Identifier Source: org_study_id

NCT00045383

Identifier Type: -

Identifier Source: nct_alias